This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber of subjects with dose limiting toxicities (DLTs)
DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.
Time frame: During the first three weeks
Number of subjects with adverse events (AEs)
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Time frame: From the time of informed consent signed through 90 days after the last dose of study drug.
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).
Time frame: Up to 2 years
Progression free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
Time frame: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).
Time frame: Up to 2 years
Duration of response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 2 years
Time to response (TTR)
Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).
Time frame: Up to 2 years
Time to progression (TTP)
Time to progression (TTP) is defined as the time from the start of the treatment to the documentation of disease progression (based on RECIST Version 1.1).
Time frame: Up to 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Time frame: Up to 2 years